510(k) · Cleared
ClearedSOLE Medial Column Fusion Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix Srl · HRS Plate, Fixation, Bone
Cleared on Apr 20, 2021 as substantially equivalent to K203511 (Paragon 28, Inc., 2020) and 3 other predicates after an 89-day review. Its family tree reaches back 14 generations to 1979.
- Decided
- Apr 20, 2021
- Review
- 89 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K792022 (1979). 220 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 10 generations between
- 3 generations backK140769 Variax 2 SystemStryker Trauma AG · 2014
- 2 generations backK173135 VariAx 2 SystemStryker GmbH · 2017
- 1 generation backK180500 VariAx 2 SystemStryker GmbH · 2018
- This deviceK210157 SOLE Medial Column Fusion PlateOrthofix Srl · 2021
Show all 14 generations
- Root · 14 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 13 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 12 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 11 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 10 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 9 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 8 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 7 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 6 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 5 generations backK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- 4 generations backK132502 Variax 2 SystemStryker Trauma AG · 2013
- 3 generations backK140769 Variax 2 SystemStryker Trauma AG · 2014
- 2 generations backK173135 VariAx 2 SystemStryker GmbH · 2017
- 1 generation backK180500 VariAx 2 SystemStryker GmbH · 2018
- This deviceK210157 SOLE Medial Column Fusion PlateOrthofix Srl · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −13 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −12 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −11 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −10 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −9 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −8 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −7 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −6 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| −5 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| −4 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
| −3 | K140769 | Variax 2 System | Stryker Trauma AG | 2014 | — |
| −2 | K173135 | VariAx 2 System | Stryker GmbH | 2017 | — |
| −1 | K180500 | VariAx 2 System | Stryker GmbH | 2018 | — |
| 0 (this device) | K210157 | SOLE Medial Column Fusion Plate | Orthofix Srl | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 14 | 0 |
| 1997 | 6 | 0 |
| 1998 | 11 | 0 |
| 1999 | 8 | 0 |
| 2000 | 17 | 0 |
| 2001 | 20 | 0 |
| 2002 | 14 | 0 |
| 2003 | 7 | 0 |
| 2004 | 13 | 0 |
| 2005 | 12 | 0 |
| 2006 | 13 | 0 |
| 2007 | 6 | 0 |
| 2008 | 10 | 0 |
| 2009 | 8 | 0 |
| 2010 | 11 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203511 | Baby Gorilla/Gorilla Plating SystemSummary page 4…evice 510(k) Manufacturer Number Baby Gorilla/Gorilla Plating System (formerly K203511 Paragon 28, Inc. ParaLock Plating SystemTM) Additional Predicate Devices VariAx 2 System… | 2020 |
| * | K180500 | VariAx 2 SystemSummary page 4…Plating System (formerly K203511 Paragon 28, Inc. ParaLock Plating SystemTM) Additional Predicate Devices VariAx 2 System K180500 Stryker GmbH VLP Foot, Plating, Screw System K090675 Smith & Nephew, Inc Salvation 3Di Plating System… | 2018 |
| * | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSummary page 4…SystemTM) Additional Predicate Devices VariAx 2 System K180500 Stryker GmbH VLP Foot, Plating, Screw System K090675 Smith & Nephew, Inc Salvation 3Di Plating System K140792 Wright Medical Reference Devices Orthofi… | 2009 |
| * | K140792 | Salvation 3DI Plating SystemSummary page 4…K180500 Stryker GmbH VLP Foot, Plating, Screw System K090675 Smith & Nephew, Inc Salvation 3Di Plating System K140792 Wright Medical Reference Devices Orthofix Fixation Screws with HA coated K974186 Orthofix Srl Veronail Screw… | 2014 |
| † | K974186 | Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating | 1998 |
| † | K053261 | Orthofix Titanium Nailing Systems | 2005 |
| † | K173458 | ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 42 years and passes through 11 companies; a new generation was cleared every 1.8 years on median.
- 42 of the 220 ancestors have a recall of any class.
- 5 other devices also cite its predicate K203511.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The SOLE™ Medial Column Fusion Plate is intended to provide bone fixation.
The SOLE™ Medial Column Fusion Plate is indicated for orthopedic applications within the anatomical area of the foot and ankle, including but not limited to the medial column (consisting of the first metatarsal, medial cuneiform, navicular and talus). Specific indicated procedures include:
- Arthrodesis;
- Joint depression stabilization;
- Fracture and/or osteotomy fixation;
- Reconstruction;
- Revision
to be performed for conditions such as Charcot neuroarthropathy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210157: SOLE Medial Column Fusion Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210157
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026